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Could a gel heal parasite skin sores? new study begins

NCT ID NCT07149753

Disease control Sponsor: Universidad Industrial de Santander Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tests a gel made with the drug miltefosine for people with uncomplicated cutaneous leishmaniasis, a skin infection from a parasite. Fifteen adults will apply the gel to their sores daily for 28 days. The main goal is to see if the gel is safe and if it helps the sores heal, to decide whether to test it in larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
miltefosine gel (applied to the skin)
What this could lead to
If it works, this could lead to a simpler, topical treatment for cutaneous leishmaniasis, avoiding the need for injections or pills.
What could go wrong
This is a very early Phase 1 pilot with only 15 people. It is designed mainly to check safety, not to prove the gel works. The gel may not heal the sores or could cause skin irritation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of confirmed cutaneous leishmaniasis (CL) * Age: 18 - 65 years. * Patients who have 1-4 CL skin lesions with a diameter of 1-4 cm, with an evolution time of more than one month and not located on the face, ears, or joints. * Patients WITHOUT suspected complicated CL (large regional lymphadenopathy, several large lesions spread to different parts of the body); NO mucosal leishmaniasis and NO suspicion of unusual leishmaniasis syndromes (e.g., recurrent leishmaniasis, diffuse or disseminated CL). * Patients with NO history of systemic antileishmania treatment within 8 weeks prior to starting the study. * Patients WITHOUT treatment failure with local therapy (intralesional antimonial injections or thermotherapy) or systemic therapy. Exclusion Criteria: * Pregnant or lactating women; women of reproductive age who refuse to use contraception until 45 days after treatment ends. * Patients with cardiovascular, hepatic, or renal impairment or who report underlying diseases that medically compromise their participation in this study. * Patients who report a history of immunodeficiency.

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Conditions

The condition(s) this trial relates to.

cutaneous leishmaniasis mucocutaneous leishmaniasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cutaneous leishmaniasis Cutaneous leishmaniasis, american Topical administration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Calle 158 No. 20-95 Cañaveral

    Floridablanca, Santander Department, Colombia

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